1. Clinical Trial Agreements (CTAs): Standard Terms and Conditions
Cara Martinoli
Clinical Research Attorney, Clinical Trial Office
Tara Keating, J.D.
Agreement Associate, Clinical Trial Office/Grants & Contracts
January 2018

2. Today’s Discussion The Role of the Clinical Trial Office (CTO)
Process-CDAs
Standard Terms and Conditions in CTAs
Use/Ownership of Study Data
Use of Protected Health Information (PHI)
Confidential Information
Publication
Intellectual Property
Access to Records and Site Monitoring
Indemnification
Subject Injury
Termination
Payment Terms
Process- VelosCT
Questions

3. Role of the CTO
The Clinical Trial Office (CTO) supports clinical trials and clinical research which utilizes BMC clinical infrastructure by managing the financial, legal, and administrative components of such research in conjunction with Principal Investigators and Study Teams. The CTO assists in the following functional areas: study initiation, financial and billing management, reporting and auditing, and account reconciliation and closeout.
During study initiation, the CTO performs Medicare Coverage Analyses (MCAs), develops Billing Grids, and develops and negotiates clinical trial budgets with research sponsors. The CTO also reviews, negotiates, and executes clinical trial agreements and confidential disclosure agreements. After account set up, the CTO assists with managing the finances of each study and reviews, negotiates, and executes any necessary agreement amendments.
The primary volume of the work processed by the CTO is industry-sponsored clinical trials, which is the focus of our discussion today.

4. Process- Confidential Disclosure Agreements (CDAs)
Sites are required to sign CDAs prior to beginning the site initiation process. This document allows the PI to receive the Sponsor’s Protocol and other study related information in order to determine whether we are willing to participate.
A CDA is also necessary prior to discussion for a PI-initiated study in order to protect the PI’s ideas.
It also covers the exchange of information during the CTA negotiation process until the CTA is fully executed.
CDAs must be reviewed by the CTO and cannot be signed by the PI prior to such review. The CTO will advise as to the required signatures after the CDA is finalized for signature.

5. Standard Terms and Conditions in CTAs

6. Use/Ownership of Study Data
Ideally, BMC would own study data/results generated here at BMC and Sponsor would be provided a license to use such data/results to extent necessary to accomplish the study at hand. However, most industry sponsors will not agree to these terms within the context of sponsor-initiated clinical trials. It is acceptable for Sponsor to own study results/data, but it should be clear that the Institution owns subject medical records and other original source documentation (other than case report forms).
BMC Use of Data/Results: BMC must reserve the right to use the results/data for publication, patient care, internal research and teaching purposes, and as required by law.

7. Use of Protected Health Information (PHI)
Limited Use of PHI: The privacy of BMC subjects must protected in accordance with the applicable laws and regulations. Accordingly, Sponsor must agree to only use and disclose PHI to the extent permitted by the IRB-approved Informed Consent Form and/or HIPAA Authorization and as required by law.
Broader Use of Deidentified Data: Where broader use and disclosure is requested, subject data should be “deidentified” as that term is defined by HIPAA. BMC prefers that the “deidentification” of subject data/PHI be performed by BMC personnel; where BMC personnel performs this function the budget should be adjusted accordingly to account for additional personnel time and effort. Where a Sponsor or other third party would perform this deidentification function, a Business Associate Agreement must be executed.

8. Confidential Information
Definition: It is always preferable to have confidential information marked as “confidential” at the time of disclosure as it removes any ambiguity. However, most industry sponsors are not willing to take on the burden of marking their documents. Thus, it is acceptable to move forward without a marking requirement but the definition of confidential information should be tightened to be as narrow as possible.
Note: Beware of definitions that include study data and results as defining them as confidential could interfere with our ability to publish in academic journals. A carve out should be created which allows the PI to use the confidential information in accordance with the publication section.
Scope: Confidential information should only be used for the study and as required by law and should not be shared beyond those persons with a “need to know” the information.
Destruction/Return to Sponsor: BMC can agree to return or destroy confidential information at the end of the study (upon written request), although we do request that we be able to maintain one copy for legal and compliance purposes (subject to continuing obligations of the confidentiality).
Term: Obligations of confidentiality can last anywhere from 5 to 10 years from the end of a study. It is not acceptable to accept an indefinite obligation of confidentiality.

9. Publication
As an academic medical center, BMC must reserve the right to publish BMC data/results by some date certain as the right to publish goes to the core of our mission. However, it is acceptable to agree to some conditions surrounding publications as outlined below.
Multi-Center Publication: It is common for industry-sponsored clinical trials to put together a multi-center publication which would precede any individual site publications. For a multi-center trial, it is acceptable to agree that our individual right to publish may be delayed until a multi-center publication has been made. However, in a multi-center trial, we must be free to independently publish by some date certain after the conclusion of the trial (12-18 months is the industry standard), the publication of the multi-center publication, or a decision that there will not be a multi-center publication.
Single Site Publication: For a single-site trial, there should be no delay in publication after the completion the study other than for Sponsor review of abstracts/manuscripts for intellectual property or Sponsor confidential information. The standard initial review periods are 30 days for an initial review and an additional 60 days in the event that the publication actually contains intellectual property. BMC may agree to longer delays in some instances but in no event should a delay exceed 120 days.

10. Intellectual Property
Sponsor IP: In a sponsor-initiated clinical trial, BMC may allow the Sponsor to own certain inventions made by our investigators and study staff. It would be ideal if Sponsor’s ownership only applies to inventions made (conceived and reduced to practice) in or directly related to the performance of the study and that constitute new uses or modifications of the study intervention.
BMC IP: In regards to BMC IP (IP beyond the definition of Sponsor IP), it is acceptable to grant the Sponsor a noncommercial, non-exclusive, royalty-free license to use the Institution’s study IP, plus the option to negotiate an exclusive commercial license.

11. Access to Records and Site Monitoring
Access to Records: Sponsor should agree that all access to records will be in accordance with subjects’ informed consent form, institutional policy, and applicable law. If Sponsor will not agree to the reference to institutional policy, it must be made clear that any access to copies of subject medical records will only be provided on the BMC’s premises and in accordance with the consent.
Site Monitoring: Sponsor should agree that site monitoring will be performed in accordance with subjects’ informed consent form, institutional policy, and applicable law. It is preferable that the Sponsor agree to provide reasonable, advance notice of a monitoring visit and that it be scheduled at mutually agreeable times. The concern here is that we must ensure that we are adequately staffed so that BMC personnel is available to assist as needed without disrupting patient care.

12. Indemnification
An indemnification clause is a contractual provision in which one party agrees to answer for any liability or harm that the other party might incur.
Sponsor Obligations: The Sponsor must agree to provide indemnification for losses resulting from the following:
Administration of the Study Drug/Device
Procedures required under the Protocol
Use of the Study Data, results, and PHI
Use of Study IP
Sponsor’s negligence
Institution Obligations: BMC prefers not to offer indemnification to industry sponsors, but will, if necessary, provide limited indemnification for BMC’s negligence or willful misconduct, failure to conduct the Trial in accordance with protocol or applicable laws.

13. Subject Injury
Industry sponsor must agree to pay for the costs of diagnosis, treatment, and care needed to treat research related injuries within industry-sponsored Clinical Trials.
Scope of Commitment: Ideally, a Sponsor would agree to pay for injuries that result from participation in the Study. However, if the Sponsor will not agree to this broad obligation, an acceptable alternative would be to agree that Sponsor will pay for injuries that result from use of the Study Drug/Device/Biologic, a procedure required under the Protocol, and Sponsor’s negligence.
Permitted Carve Outs: BMC can agree to limit Sponsor’s subject injury obligation to the extent that the research injury is due to any of the following: the negligence of BMC, violation of law, or breach of the Protocol.

14. Termination
Termination for Safety: BMC must have the right to immediately terminate the study in order to protect the health, safety, and welfare of its subjects. In addition, Sponsor should also provide for continued treatment of subjects, at the Sponsor’s expense, to the extent medically necessary in the prudent medical opinion of the PI.
Other Reasons for Termination: Beyond the right to terminate above, BMC may request the right to terminate for all or all of the following reasons: without cause upon thirty days notice to Sponsor, in the event of a material breach where such breach has not been cured within a specified time period, where the PI is no longer able to conduct the study and a suitable replacement cannot be found, or where IRB approval is revoked.
Cost Considerations: In the event of termination, Sponsor should agree to pay for all costs and non-cancelable obligations incurred up through the effective date of termination.

15. Payment Terms
Although payment terms will vary from agreement to agreement, the same general principles apply.
Payment terms should be clearly drafted:
When will BMC be paid?
What steps are necessary to trigger payments (invoicing, CRF submission, back up documentation, etc.)?
What method of payment will be used?
What percentage of payment will be withheld?
Final Budget Incorporated: The final revised budget, as negotiated and approved by a Financial Analyst, should be incorporated into the CTA. Please note that this final incorporated budget is not BMC’s internal budget.

16. Process- Initiating CTO Review
Once Sponsor and the Study Team are ready to proceed with study initiation, the CTO will begin their review of the study documents via VelosCT.
In order to Initiate this review, the Study Team must create a VelosCT submission, upload the required documents, and complete the Study Summary Related Set Up Form.
The Study Summary Related Form (being renamed the Study Initiation Form) will flow to the CTO Inbox.
The CTO Inbox is monitored daily and the form will be routed to the appropriate Clinical Trial Financial Analyst (CTFA).
The CTFA will an introduction to the process with next steps and timelines outlined.
Work will then begin on the coverage analysis and contract terms.
Budget work will begin when a substantial portion of the coverage analysis is complete.
Contract terms and budgets are negotiated with sponsors with ongoing input from the PI and study team.

17. Questions?

18. Contact Information
Clinical Trial Office
Terry Stone
Director, Clinical Trial Office
Cara Martinoli
Clinical Research Attorney
Tara Keating
Agreement Associate